CLASS II Device recall · Reported 26 Oct 2016 · FDA Enforcement Report

Vitros Chemistry Products GLU Slides recalled

Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products GLU Slides, distributed nationwide in the US. The recall was initiated on 11 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCurrent/In-date GENs 10, 11, 20 through 31

Quantity recalledUS: 192,459 sales units; Foreign: 231,710 sales units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0089-2017
FDA event ID: 74950
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 11 Aug 2016
FDA classified: 17 Oct 2016
Reported: 26 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Potency & Assay
Device type: Insulin Pumps & Glucose Monitors

Timeline

11 Aug 2016	Recall initiated by company
17 Oct 2016	Classified by FDA	+67 days
26 Oct 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays. Ortho also tested several compounds following industry standard CLSI EP7-A2 for potential interference on VITROS GLU Slides during validation testing for a proposed change and confirmed Dextran 40 and Glutathione may interfere with current VITROS GLU Slides.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System

Where it was distributed

Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Current/In-date GENs 10, 11, 20 through 31

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 74950

This product is part of a recall event; the main page for the event is Vitros Chemistry Products Trig Slides recalled.

Reported	Class	Recall	Company	Reason	Where
26 Oct 2016	CLASS II	Vitros Chemistry Products Trig Slides recalled	Ortho-Clinical Diagnostics	Potency & Assay	Nationwide
26 Oct 2016	CLASS II	Vitros Chemistry Products LAC Slides recalled	Ortho-Clinical Diagnostics	Potency & Assay	Nationwide
26 Oct 2016	CLASS II	Vitros Chemistry Products Uric Slides recalled	Ortho-Clinical Diagnostics	Potency & Assay	Nationwide

More recalls from Ortho-Clinical Diagnostics

All 311

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Device	CLASS II	Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
24 Sep 2025Device	CLASS II	Vitros Chemistry Products LAC Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
27 Aug 2025Device	CLASS II	Vitros Chemistry Products Ca Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides (Japan) recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide

Other Insulin Pumps & Glucose Monitors recalls

All 459

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
15 Jul 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Device Malfunction	CA
8 Jul 2026Device	CLASS I	Omnipod (Eros) Pod recalled by Insulet	Insulet	Packaging Defects	Nationwide